As a means of treating irregular heartbeats, doctors often place a small device called an implantable cardioverter defibrillator, also known as an ICD, in a person's chest or abdomen. ICDs utilize electrical pulses to help control life-threatening irregular heartbeats, especially the type that can cause sudden cardiac arrest which can lead to death within minutes if not treated. Thin wires connect the ICD to a person's heart. If an abnormal heartbeat is detected the device will deliver an electric shock to restore a normal heartbeat.
Studies show that ICDs have been successful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation.
To be considered as a candidate for an ICD, the American Heart Association recommends that the irregular heartbeat first be life threatening and that doctors have ruled out other causes of the irregularity, like heart attack; inadequate blood flow to the heart; or drug use.
The first implantable cardioverter defibrillator was created by Michel Mirowski and Stephen Heilman in 1975. The device was first implanted in a human in 1980.
Since that time many technological advances have been made to the device. Modern devices are smaller and lighter than the device that was used in 1980. In addition to having full pacemaker capabilities, all modern ICDs are capable of overdrive pacing which can often terminate ventricular tachycardia without resorting to shock therapy. In 2016, Medtronic received FDA approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator SureScan device which automatically tailors the therapy to individual patients by adjusting pace rates. Physicians will now be able to verify the effectiveness of left ventricular pacing, which is beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat in the past.
Common complications associated with ICDs include:
- Minor bleeding at the implantation site
- Major bleeding requiring blood transfusions
- Introduction of air into the space between the lung and chest wall requiring tube drainage
- Perforation of the heart muscle by the leads
- Activation of an intractably fast heart rhythm
When a medical device is not working appropriately, a recall is usually issued by the manufacturer. When this happens with an implanted device, it usually does not mean that it needs to be removed. Instead, it means that a doctor should check the device and establish a plan to correct the issue.
When a recall is made, it can fall under three potential categories; Class I, Class II, and Class III. Class I recalls are the most serious and harmful. The FDA states Class I recalls as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls are described by the FDA as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recalls are for problems that are unlikely to cause patient harm. The FDA describes a Class III recall as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Over the years several ICDs have had to be recalled. Riata and Riata ST leads, which are wires that connect an implantable cardioverter defibrillator to the heart in order to monitor heart rhythms had a recall issued by their manufacturer, St. Jude Medical Inc., due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. The manufacturer stopped selling those leads when it realized that an issue existed but more than 227,000 Riata leads had been distributed worldwide at that point. As of 2011, approximately 79,000 Riata leads remained implanted in patients in the United States.
The Food and Drug Administration (FDA) became aware of an increase in frequency of reported Riata insulation failures, which began around four years after being implanted in a patient. Insulation failure may cause some of the electrical conductors inside Riata leads to move within or move entirely outside the outer lead insulation. The FDA issued a statement recommending patients to undergo an x-ray to determine the severity of the situation.
Last year, four years after the company stopped selling the product, St. Jude Medical agreed to pay $14.25 million to settle 950 pending legal claims. There are three lawsuits are not included in the settlement.
More recently, the FDA issued a class I recall of 447 St. Jude-made Optisure leads due to a manufacturing defect that may have introduced damage to the wires' insulation. The recall was issued after an internal investigation showed problems with cuts to the insulation of the lead which could potentially lead to an electrical malfunction in which the defibrillator cannot send the right amount of voltage. At the time of the recall, it was thought that only nine patients in the United States were implanted with the compromised leads.
If you have suffered adverse health effects as a result of a faulty, implantable cardioverter defibrillator, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.